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Outlook Therapeutics® Reports Financial Results for Fiscal Year 2023 and Reiterates ONS-5010 Clinical and Regulatory Path Forward in the U.S. and EU
Commencement of ONS-5010 NORSE EIGHT clinical trial targeted for first calendar quarter of 2024Company reaffirms potential for European approval for ONS-5010
About this update from Outlook Therapeutics, Inc.
[{"type":"text","content":"Commencement of ONS-5010 NORSE EIGHT clinical trial targeted for first calendar quarter of 2024Company reaffirms potential for European approval for ONS-5010 with Marketing Authorization Application (MAA) decision date anticipated in the first half of 2024 Resubmission of the ONS-5010 Biologics License Application (BLA) expected by the end of calendar year 2024 ISELIN, N.J., Dec. 22, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve U.S. Food and Drug Administration (FDA) approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, today announced recent corporate highlights and financial results for its fiscal year ended September 30, 2023. “We remain committed to working with the FDA to design and undertake the additional clinical study for ONS-5010 that, if successful, will satisfy the FDA’s requirements for approval,” commented Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics. “The patient need for an ophthalmic approved bevacizumab remains and we are steadfast in our mission to meet this need.” Upcoming Anticipated Milestones FDA response on NORSE EIGHT Special Protocol Assessment (SPA) in early February 2024;Commencement of NORSE EIGHT expected in first calendar quarter of 2024;MAA decision date in the EU for ONS-5010 expected targeted for first half of 2024;Completion of NORSE EIGHT in the U.S. anticipated in 2024; andResubmission of the ONS-5010 BLA expected by the end of calendar year 2024. ONS-5010 / LYTENAVA™ (bevacizumab-vikg) Regulatory Update As previously announced, following a Type A meeting with the FDA held in October 2023, the FDA informed Outlook Therapeutics that it can conduct a non-inferiority study evaluating ONS-5010 versus ranibizumab in a 3-month study of treatment naïve patients with a primary efficacy endpoint at 2 months. Subsequently, as discussed with and recommended by the FDA, Outlook Therapeutics submitted a clinical trial protocol and requested a Type A meeting with the FDA for feedback. The FDA has already provided written feedback on the protocol, which Outlook Therapeutics has incorporated. The revised protocol is the subject of the SPA request, in which Outlook Therapeutics is seeking further confirmation from the FDA that NORSE EIGHT, if successful, address...